For decades, neuropsychiatrists have recognized the profound therapeutic potential of entactogens (compounds which promote empathy and emotional openness), but their clinical path was blocked by legal, scientific, and regulatory barriers. In recent years, a thaw in research has allowed these revolutionary therapies to be evaluated in clinical studies, with an eventual goal of FDA approval and commercialization.   

 

Based in San Francisco, Arcadia is working to develop a new generation of safe and effective entactogens. Its strategy is focused on engineering novel forms of molecules with an existing history of human use to improve clinical efficacy while reducing physical and psychological risks. This vision has led to the development of Arcadia’s lead candidate, AM-1002, a non-racemic formulation of MDMA.  

 

AM-1002 has been developed to be non-neurotoxic and is not expected to induce hyperthermia, a common side effect of MDMA. Its flexible dosing profile allows greater flexibility in the primary dosing sessions and potentially as a maintenance therapy. Arcadia holds a Composition of Matter patent for AM-1002, which grants exclusive rights to the specific drug formulation. 

 

AM-1002 is engineered to release serotonin and oxytocin with greater selectivity, which drives a more targeted therapeutic effect without the significant stimulant-like effects thought to underlie MDMA’s abuse liability and hyperthermic response. 

 

Supported by a strong team with deep expertise in pharmaceutical development and neuropsychiatric drug discovery, AM-1002 has an active FDA Investigational New Drug (IND) application with the U.S. FDA and is Phase 1 ready following completion of its preclinical toxicology program.   

 

Arcadia is now preparing for its next milestone: a Phase 1/1b trial is set to begin this year. The study will include healthy volunteers (with an intended expansion cohort consisting of GAD patients). There are approximately 20 million adults in the U.S. estimated to suffer from GAD in any given year and ~50% do not respond to first line treatments. Arcadia aims to provide safer and more effective treatment to patients who are underserved by existing therapies.